RELAY^®PRO GETS FDA APPROVAL FOR DISSECTION AND TRANSECTION

Terumo Aortic announced that the US Food and Drug Administration (FDA) has granted approval for the Relay^®Pro Thoracic Stent-Graft device for the treatment of dissection and transection in the United States.

Relay^®Pro delivers uncompromised clinical performance in the lowest commercially available profile and is indicated for all pathologies of the descending thoracic artery; aneurysms, penetrating atherosclerotic ulcers, transection and dissection. Relay^®Pro offers unparalleled accuracy, proven efficacy and durability as well as the widest range of sizes, tapering and configurations on the market, designed to expand the treatment of thoracic endovascular aortic repair (TEVAR) to patients with smaller access vessels.

This approval follows the excellent results from recent studies on Relay^®Pro Dissection (RelayPro-D) and Relay^®Pro traumatic injury (RelayPro-T).

The Pro-D study was a prospective, multicenter pivotal trial conducted in 22 US centres and enrolled 56 patients with acute, complicated Type B aortic dissection. Approximately two-thirds of the subjects had dissection extension to the iliac arteries. The primary endpoint of all-cause mortality at 30 days was 1.8% and demonstrated a clear early survival benefit. Patients will be followed for 5 years.

The Pro-T study was a prospective, multicenter pivotal study that enrolled 50 patients in 16 US centres. The purpose of the study was to assess the performance of Relay^®Pro for the treatment of transection. The primary endpoint of the trial was all-cause mortality at 30 days was 2% with follow-up continuing for five years.

Furthermore, with the Relay^®Pro “Upon Request” program, there are approximately 2000 stent-graft configurations approved by the FDA; this truly comprehensive portfolio allows physicians unparalleled choice and versatility allowing physicians to select devices that best fit the anatomical needs of each individual patient.

The Relay^®Pro Thoracic Stent Graft received CE Mark approval in 2017 and FDA approval in 2021 for the treatment of patients with Thoracic Aortic Aneurysms (TAA) and Penetrating Atherosclerotic Ulcers (PAUs).

www.terumo.com